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New Study Demonstrates that DexCom CGM Significantly Reduces Hypoglycaemia in People with Type 1 Diabetes on MDI

VIENNA, February 20, 2018 /PRNewswire/ --

Usage of DexCom CGM reduced the incidence of hypoglycaemic events by 72% for high risk individuals with type 1 diabetes on multiple daily injections (MDI) of insulin 

DexCom, Inc. (DXCM), has today released the findings of the HypoDE study, a multi-centre, randomised controlled trial (RCT) which was discussed on Friday 15th February at ATTD. The study found that the use of Dexcom continuous glucose monitoring (CGM) reduces the frequency and severity of hypoglycaemic events among high-risk individuals with type 1 diabetes treated with multiple daily injections (MDI) of insulin.

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Hypoglycaemia remains a key limiting factor in achieving optimal glycaemic control in people with type 1 diabetes, and the vast majority of these individuals are treated with MDI globally. These results represent a breakthrough for individuals with type 1 diabetes and impaired hypoglycaemia awareness, demonstrating the potential of Dexcom CGM to help avoid low glucose levels and severe hypoglycaemic events, which were reduced by over two-thirds in the study.

During the HypoDE study, participants also achieved a more stable glucose profile using Dexcom CGM and therefore reduced their glycaemic variability, a risk factor for hypoglycaemia.

"We looked at individuals with impaired hypoglycaemia awareness (IHA) and severe hypoglycaemia (SH), high risk groups which have often been excluded from clinical trials to date," said Lutz Heinemann, Investigator, Science Consulting in Diabetes. "We found that the Dexcom CGM system reduces hypoglycaemic events through the availability of low glucose alarms and use of trend information, which enables individuals to proactively respond to falling or near-low glucose values. This is especially helpful to patients with IHA, or other patients at night when they are most vulnerable to potentially dangerous hypoglycaemic events."

The study included 149 randomised participants and was conducted in three phases: baseline phase, therapy phase and follow-up phase. 141 people participated in the follow-up phase between March 2016 and January 2017.

Primary Outcome  

  • Incidence of hypoglycaemic events decreased by 72% for participants in the rtCGM group (incidence rate ratio 0·28, [95% CI 0·20-0·39], p<0·0001).

Secondary Outcomes  

  • In the Dexcom CGM group, the number of nocturnal hypoglycaemic events over 28 days was reduced from an average of 2.3 events at baseline to 1 event at follow-up, versus an increase of 2.4 to 2.7 in the control group.
  • Dexcom CGM reduced the rate of SH by approximately 50% when compared to the control group.
  • Dexcom CGM use improved glucose control; the CGM group saw a reduction in glycaemic variability to 34.1%, from 39.3% at baseline.

John Lister, General Manager, Dexcom EMEA, said: "We are committed to enhancing people's quality of life with CGM technology that provides peace of mind with real-time, accurate results. We're pleased the findings demonstrate that usage of Dexcom CGM technology reduces the frequency and severity of hypoglycaemic events, which can be distressing for the patient and their family; and can help people to achieve a more stable blood glucose profile, which can reduce the risk of associated health complications."

For more information on the study, please visit The Lancet Journal here: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30297-6/fulltext.

Methodology 

The HypoDE study was a multi-centre, randomised, open label parallel study conducted at 12 diabetes practices in Germany. Eligible participants had type 1 diabetes and a history of impaired hypoglycaemia awareness and/or severe hypoglycaemia (SH) during the previous year. All participants wore a blinded rtCGM system (Dexcom G4® PLATINUM with software 505) for 28 days and were then randomised to 26 weeks of unblinded rtCGM using Dexcom G5 Mobile or self-monitoring of blood glucose (SMBG). The control group wore a blinded rtCGM system (Dexcom G4 PLATINUM with software 505) during the follow-up phase (weeks 22 to 26). The primary outcome was the difference of low glucose events, defined as spending at least 20 minutes in a glucose range ≤3·0 mmol/L (≤54 mg/dL). The trial is registered with ClinicalTrials.gov: NCT02671968.

About DexCom, Inc. 

Founded in 1999, DexCom, Inc. has corporate offices in San Diego, California, EMEA headquarters in Edinburgh, Scotland and users in 39 countries around the world. At Dexcom, we are transforming diabetes care and management by providing superior continuous glucose monitoring (CGM) technology to help people with type 1 diabetes and healthcare professionals better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class-while empowering our community to take control of diabetes. For more information on Dexcom CGM, visit www.dexcom.com/global.